• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number 9500-35
Device Problem Invalid Sensing (2293)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Lethargy (2560)
Event Date 06/04/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and loss of consciousness.
 
Event Description
Patient's mother contacted dexcom on 06/08/2016 to report that the patient experienced an adverse event on (b)(6) 2016. The sensor was inserted in the abdomen on (b)(6) 2016. Patient's mother stated that on (b)(6) 2016 the patient was feeling very lethargic, described her as low tone and not responding. Patient's mother tried to give her juice. After, it seemed like the patient was not responding to the juice. Patient's mother called paramedics due to the patient's pump reading 2. 4mmo/l. Before the transport paramedics checked her blood glucose (bg) from her toe and it was 3. 6mmol/l. The paramedics wanted the patient to have a sandwich and patient's mother refused to feed the patient a sandwich. Paramedics gave the patient glucose paste, then transported her to a children's hospital on (b)(6) 2016. The patient stayed at the hospital for observation. The patient was sent home on the same day after she was stable. At the time of contact, the patient was stable. No additional event or patient information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceMDS
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key5767034
MDR Text Key48710961
Report Number3004753838-2016-03643
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-35
Device Catalogue NumberSTS-GL-007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/01/2016 Patient Sequence Number: 1
-
-